NL-OMON49717
Recruiting
Phase 3
A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734*) in Participants with Moderate COVID-19 Compared to Standard of Care Treatment - Remdesivir in Participants with Moderate COVID-19
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Gilead Sciences
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible for
- •participation in this study:
- •1\) Willing and able to provide written informed consent (participants \>\= 18
- •years of age) or assent (participants \>\= 12 and \< 18 years of age,
- •where locally and nationally approved) prior to performing study procedures.
- •For participants \>\= 12 and \< 18 years of age, a parent or
- •legal guardian willing and able to provide written informed consent prior to
- •performing study procedures
- •2\) Aged \>\= 18 years (at all sites), or aged \>\= 12 and \< 18 years of age weighing
- •\>\= 40 kg (where permitted according to local law and approved nationally and by
Exclusion Criteria
- •Subjects who meet anyof the following exclusion criteria are not to be enrolled
- •in this study:
- •1\) Participation in any other clinical trial of an experimental agent treatment
- •for COVID\-19
- •2\) Concurrent treatment or planned concurrent treatment with other agents with
- •actual or possible direct acting antiviral activity against SARS\-CoV\-2
- •3\) Requiring mechanical ventilation at screening
- •4\) ALT or AST \> 5 x ULN
- •Note: if per local practice only ALT is routinely is routinely measured,
- •exclusion criteria will be evaluated on ALT alone
Outcomes
Primary Outcomes
Not specified
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